Study of Cimzia for the Treatment of Ulcerative Colitis

NCT01090154 | Completed Phase 2 DMC

• 2 other identifiers: 37823CZP-UC-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective treatment for patients with Ulcerative colitis.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; UC; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• To determine the proportion of patients achieving clinical response determined by patient reported symptoms and investigator's assessment of mucosal healing via endoscopy measured by Total Mayo Score at Week 14 compared to Week 0.

  Clinical response is defined as a decrease in the Total Mayo Score of at least 3 points by Week 14 compared to Week 0.

  Week 14

Secondary Outcomes (9)

• To determine the proportion of patients achieving clinical remission determined by patient reported symptoms and investigator's assessment of mucosal healing via endoscopy measured by Total Mayo Score at Week 14 compared to Week 0.

  Week 14

• To determine the proportion of patients achieving clinical response or clinical remission at week 54 per the same criteria as listed above.

  Week 54

• To determine the proportion of patients achieving mucosal healing at weeks 14 and 54 defined as a Mayo endoscopic subscore less than 2.

  Week 14/54

• To determine the corticosteroid-sparing effects of certolizumab pegol over a years treatment time.

  Week 54

• To determine the colectomy rate between week 0 and week 54

  Week 54

Study Arms (1)

Cimzia

EXPERIMENTAL

Treatment with open label Cimzia (certolizumab pegol)

Drug: Cimzia

Interventions

Cimzia DRUG

Cimzia 400mg administered via two 200mg subcutaneous injections at weeks 0, 2, and 4; followed by every 4 week dosing.

Also known as: certolizumab pegol

Cimzia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-75 years
• Established diagnosis of UC (by routine clinical, radiologic, endoscopic, and histologic criteria) of at least 3 months duration
• Moderate to severe active disease, defined by Mayo score \> 6 with endoscopic subscore \> 2
• Ability to understand the study protocol and treatments, willingness to comply with all study requirements, and ability to provide informed consent
• No history of prior tuberculosis (TB), no signs or symptoms of active TB, and negative Quantiferon gold test or PPD and chest X-ray showing no active or latent TB at screening or within the 6 months prior to the screening visit.
• Screening blood tests must meet the following criteria: white blood cell count \> 3000/µL (with neutrophils \> 1500/µL and lymphocytes \> 500/µL), hemoglobin \> 8 g/dL, platelet count \> 100,000/µL, liver function tests \< 3 times the upper limit of normal, serum creatitine \< 1.5 mg/dL
• Screening stool sample negative for Clostriduim difficile, ova \& parasites, and aerobic pathogens, including Aeromonas, Plesiomonas, Salmonella, Shigella, Yersinia, Campylobacter, and E. coli spp.
• Medication use must meet the following criteria:
• Rectally administered topical 5-aminosalicylates (5-ASAs)/corticosteroids: must be discontinued by 1 month prior to baseline; not allowed during the study
• Oral 5-ASAs: allowed if at stable dose for at least 2 weeks prior to baseline; can remain on this stable dose during the study
• Antibiotics for UC: must be discontinued by 1 month prior to baseline; not allowed during the study
• Antidiarrheals: must be discontinued by 2 weeks prior to baseline; not allowed during the study
• Corticosteroids: allowed if at Prednisone dose equivalent of 20 mg/d or less, stable for 2 weeks prior to baseline (dose/taper during study discussed below); budesonide is allowed at a dose less than or equal to 9 mg/day if at stable dose for 2 weeks prior to baseline
• Mercaptopurine (6MP)/Azathioprine/Methotrexate: allowed if on for at least 8 weeks, at stable dose for at least 4 weeks prior to baseline; can remain on this stable dose during the study
• Anti-TNF therapy: Patients must be naive to CZP. Patients may have had prior exposure to anti-TNF therapy (e.g., infliximab, adalimumab, golimumab), however patients who are primary non-responders to more than one anti-TNF medication are excluded. Patients must have been off their prior anti-TNF medication for at least 8 weeks prior to baseline.

You may not qualify if:

• Diagnosis of Crohn's disease or indeterminate colitis, or clinical findings suggestive of Crohn's disease
• Fulminant disease, toxic megacolon, or anticipated imminent colectomy
• Presence of ileal pouch or ostomy
• Pregnancy, desire to become pregnant during the following 18 months, or breast feeding
• Surgery of any kind within 2 months of screening or anticipated surgery of any kind during the study
• Anticipated imminent hospitalization for any medical conditions
• Active ongoing infection of any kind
• Current use of total parenteral nutrition
• History of:
• Congestive heart failure or significant coronary artery disease (including myocardial infarction, percutaneous coronary intervention, or coronary artery bypass within 6 months of screening)
• Cancer
• Colonic dysplasia (except sporadic adenomas). Also, patients found to have colonic dysplasia at any time during the study will be withdrawn from the study.
• HIV, chronic or active hepatitis B or C, or patients considered at high risk for these infections (obtained by history/detailed medical chart review except for hepatitis B, which will be tested for with blood sample)
• Prior opportunistic infection within 6 months of screening or prior opportunistic infection while on other anti-TNF therapy
• Hepatic disease (cirrhosis, chronic active hepatitis, or LFT abnormalities as above)

Sponsors & Collaborators

• University of Washington: lead
• UCB Pharma: collaborator
• University of Pennsylvania: collaborator

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Scott D Lee, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Mark T Osterman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine/Division of Gastroenterology

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 19, 2010
• Study Start: December 1, 2010
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)